- United Therapeutics (Sacramento, CA)
- …and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety ... ensuring compliance, and quality in adverse effects, including individual case safety report (ICSR) adverse events, product complaints (PC), and special reporting… more
- Sumitomo Pharma (Sacramento, CA)
- …for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle ... strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety… more
- Ascendis Pharma (Palo Alto, CA)
- …Safety Database. + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure ... the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the Head,...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- Cardinal Health (Sacramento, CA)
- …policies regarding Medical Drug Information, including any MSL presentations and Medical/ Safety Review Committees + Provides pharmacovigilance support through ... internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying customer needs or knowledge gaps to… more
- AbbVie (South San Francisco, CA)
- … Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product safety team ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Safety Statistics Group (SSG) at AbbVie is an important strategic part… more
- BeOne Medicines (Emeryville, CA)
- …ongoing pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face regulatory meetings + Actively leads and develops an ... GPS product co-ordination, chairs product group meetings across GPS ** Pharmacovigilance :** + Leads and manages safety PV...across GPS ** Pharmacovigilance :** + Leads and manages safety PV processes for BeiGene and competitor products +… more
- Sumitomo Pharma (Sacramento, CA)
- …with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… more
- United Therapeutics (Sacramento, CA)
- …+ 5+ years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety and Medical Science, ... background in nursing or pharmacy and you're passionate about pharmacovigilance ! You are a team player who loves quality,...are implemented and successful. This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gilead's ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- Ascendis Pharma (Palo Alto, CA)
- … experience is highly desired. + Minimum of 8 years recent experience in Pharmacovigilance + Expert knowledge of FDA safety regulations, ICH Guidelines, and ... to the Director, Head, PV Vendor Management Team within the Global Patient Safety (GPS) organization. Under the direction of the Head, PV Vendor Management Team… more